Uzbekistan Medical Device Registration Exemptions: Scope and Boundaries

1. Key takeaways

Resolution No. 738 does provide a list of situations in which devices are either not registered or not required to be registered, but these exemptions do not constitute a channel for commercial market access. Custom-made devices, reagents not for stand-alone diagnostic use, products imported for research and clinical trials, goods for exhibitions and trade fairs, and humanitarian aid supplies imported upon a decision of the Ministry of Health each have their own specific conditions of application and boundaries. Treating an exemption as a springboard for entering the market first and selling later is one of the main reasons goods are detained at customs clearance. The decisive feature is that every exemption in the list is tied to a purpose rather than to a product: the same device may enter without registration as a research item and require full registration once it is sold as a commodity. Because the exemption is re-established on each import through the declared purpose and the actual destination of the goods, exemption planning belongs to the import operations layer of the company, not only to the regulatory affairs layer. Companies should maintain a documented mapping between each declared import purpose and the applicable exemption, together with the records that prove the actual use matched the declaration.

2. Legal basis

3. Expert insights

Insight one: the essence of the exemptions is exemption by purpose, not exemption by product. The same equipment, imported for research use, is not required to be registered; sold as a commodity, it must be registered. The decisive factor is the purpose declared at import clearance and the actual subsequent flow of the goods. This means that exemption status cannot be obtained once at the product level: it must be re-established at every import. Compliance teams that certify a product as exempt indefinitely expose themselves to enforcement findings when the goods drift from the declared purpose, because the exemption follows the shipment, not the SKU.

Insight two: import for registration procedures is the most practical exemption in the list. Resolution No. 738 lists import for the purpose of carrying out the state registration procedure among the situations not requiring registration, which solves the legality of sample imports: a company can lawfully ship samples into the country for testing without first holding a registration certificate. The boundary of this exemption, however, is strictly limited to the quantity actually needed for the registration procedure; quantities beyond that need constitute unregistered devices. Retaining the testing commission documents and the sample shipment records is the practical proof of purpose if customs or the agency asks.

Insight three: the custom-made device exemption does not scale. A custom-made device is a product made to an individual prescription for a specific patient. As soon as the same specification is produced repeatedly, the product leaves the scope of custom-made devices and returns to the ordinary registration requirements. Manufacturers taking on dental and orthopedic personalization business must distinguish genuinely custom parts from standardized products selected by model. The documentary test is the chain between the individual prescription and the production record, and that chain must exist for each unit delivered under the exemption.

Insight four: humanitarian aid and Ministry of Health orders are two independent channels. Humanitarian or gratuitous aid supplies may be imported and used without registration after a positive decision of the Ministry of Health, and products for the control of especially dangerous or epidemiologically significant infectious diseases may be exempted from registration upon a request of the Ministry of Health. Both channels are premised on a decision of the Ministry of Health and are not rights that the importer can assert on its own. Shipping first and completing the paperwork later converts a well-intended humanitarian program into a customs violation.

4. Practical recommendations

1. Maintain an import purpose versus registration status mapping table and check the applicability of the exemption before every import.
2. For sample imports, declare the quantity actually needed for the registration procedure and retain the testing commission and sample shipment records as proof of purpose.
3. For custom business, build a chain of individual prescriptions and production records to avoid being treated as scaled standardized manufacturing.
4. For humanitarian aid and epidemic control supplies, obtain the decision document of the Ministry of Health through the representative before shipment, not after.
5. Where exempt-imported products are later converted to commercial sale, complete ordinary registration before the sale begins.

5. Verification checklist

• □ The purpose of every import has been recorded and checked against the applicability of the exemption
• □ Sample import quantities match the actual needs of the registration procedure, with sample shipment records retained
• □ Custom business retains individual prescriptions and production records
• □ Decision documents of the Ministry of Health have been obtained for humanitarian aid and epidemic control supplies
• □ Exempt-imported products have not been converted to commercial sale without a registration certificate
• □ Export-only devices, where registration is needed, have been submitted separately at the request of the applicant

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with exemption planning and import compliance, contact info@grzanglobal.com.